Comparing self- and provider-collected swabbing for HPV DNA testing in female-to-male transgender adult patients: a mixed-methods biobehavioral study protocol

Abstract

BackgroundCervical cancer, nearly all cases of which are caused by one of several high-risk strains of the human papillomavirus (hr-HPV), leads to significant morbidity and mortality in individuals with a cervix. Trans masculine (TM) individuals were born with female reproductive organs and identify as male, man, transgender man, or another diverse gender identity different from their female assigned sex at birth. Routine preventive sexual health screening of TM patients is recommended, including screening for cervical cancer and other sexually transmitted infections (STIs); however, as many as one in three TM patients are not up-to-date per recommended U.S. guidelines. Among cisgender (non-transgender) women, self-swab hr.-HPV DNA testing as a primary cervical cancer screening method and self-swab specimen collection for other STIs have high levels of acceptability. No study has yet been conducted to compare the performance and acceptability of self- and provider-collected swabs for hr.-HPV DNA testing and other STIs in TM patients.MethodsThis article describes the study protocol for a mixed-methods biobehavioral investigation enrolling 150 sexually active TM to (1) assess the clinical performance and acceptability of a vaginal self-swab for hr.-HPV DNA testing compared to provider cervical swab and cervical cytology, and (2) gather acceptability data on self-collected specimens for other STIs. Study participation entails a one-time clinical visit at Fenway Health in Boston, MA comprised of informed consent, quantitative assessment, venipuncture for syphilis testing and HIV (Rapid OraQuick) testing, randomization, collection of biological specimens/biomarkers, participant and provider satisfaction survey, and qualitative exit interview. Participants are compensated $100. The primary study outcomes are concordance (kappa statistic) and performance (sensitivity and specificity) of self-collected vaginal HPV DNA specimens vs provider-collected cervical HPV swabs as a gold standard.DiscussionThis study addresses critical gaps in current clinical knowledge of sexual health in TM patients, including comparing alternative strategies for screening and diagnosis of cervical cancer, hr.-HPV, and other STIs. Findings have implications for improving the delivery of sexual health screening to this often overlooked and underserved patient population. Less-invasive patient-centered strategies may also generalize to other at-risk cisgender female populations that face barriers to timely and needed STI and cervical cancer screening.Trial registrationClinicalTrials.gov ID: NCT02401867 Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-017-2539-x) contains supplementary material, which is available to authorized users.

Risk and protective factors for mental health morbidity in a community sample of female-to-male trans-masculine adults

“…Next, participants completed a self-administered quantitative survey via an electronic tablet which included socio-demographics, resilience and social-support, discrimination and violence, and mental health. Following the survey, participants completed a clinical visit, followed by an exit interview, both of which are described elsewhere [36]. All study activities were approved by the IRB.…”

Test performance and acceptability of self- versus provider-collected swabs for high-risk HPV DNA testing in female-to-male trans masculine patients

“…Between March 2015 and September 2016, 150 TM individuals were enrolled in a study with a single visit. [ 37 ] Participants were recruited through a variety of convenience sampling methods including recruitment flyers posted at clinical care sites; facilitated referrals from medical providers and clinical staff; outreach to local organizations and venues frequented by members of the TM community; study information shared through social media, transgender websites and e-mail listserv posts; and via peer-to-peer word of mouth referrals. Interested individuals contacted study staff who administered a brief screening survey in-person or on the phone prior to enrollment.…”

The contraceptive and reproductive history and planning goals of trans-masculine adults: a mixed-methods study

“…The Institutional Review Board at Fenway Health approved all study activities. More information is available regarding study procedures in previously published literature [7].…”